Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis Situations

NCT05219357 | Unknown DMC

• 1 other identifier: NMP1873-92
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

Brief Summary

For patients undergoing a psychiatric crisis, hospitalisation is required. In developing countries specially in sub-urban or rural areas, most patients don't access intensive care. In India, AYUSH system of medical care is widely used, including crisis resolution and community treatment have been widely implemented in various mental health systems. However, evidence to support their effectiveness has remained very low. Present study is designed as community based participatory research, where Ayurveda treatment , a short-term, specialised, crisis intervention is provided by community outreach team.

Conditions

Psychiatric Disorder

Keywords

Ayurveda; Mental Health; Emergencies; Community Based Participatory Research

Outcome Measures

Primary Outcomes (2)

• Brief Symptom Inventory

  Brief Symptom Inventory was used to assess self-report of psychological problems and symptom severity

  Change from baseline to 48 hours and 7th-days of intervention

• Length of Emergency hospital stay

  Length of stay is defined as the time between patient triage and discharge from the emergency department

  Hours spent in the Emergency Department (ED), measured at the index ED visit (Day 0)

Secondary Outcomes (7)

• The Kessler Psychological Distress Scale (K10)

  Change from baseline to 3rd and 7th-days of intervention

• The Psychological Outcome Profiles instrument

  From Baseline to 3rd and 7th-days of intervention

• Agitation Calmness Evaluation Scale (ACES)

  From Baseline to 48 hours and 7th-days of intervention

• Positive and Negative Syndrome Scale;

  From Baseline to 48 hours and 7th-days of intervention

• Satisfaction with acute care

  From Baseline to 3rd and 7th-days of intervention

Other Outcomes (1)

• Death by Suicide

  From Index ED visit to 30 days

Study Arms (2)

Usual Care Group (UCG)

ACTIVE COMPARATOR

The usual care control group received care only on hospital wards during episodes

Drug: Usual-Care

Ayu Care Group (ACG)

OTHER

Multidisciplinary Ayurveda based treatment team aimed to manage acute crises of patients in the community settings or at their home if feasible.

Other: Ayu-Care

Interventions

Ayu-Care OTHER

Ayurveda treatment modalities includes three parts to manage mental health Satwawajay Chikitsa, Yuktivyapashray and Daivyapashray Chikitsa. It is based on personalised whole person approach.

Also known as: Ayurveda

Ayu Care Group (ACG)

Usual-Care DRUG

Management strategies includes restraints, emergency medications, behavioral interventions, with a special focus on the pharmacological interventions.

Usual Care Group (UCG)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presenting with a psychiatric complaint.
• Male or female patients at least 18 years of age.
• Each patient, or a patient's legal representative (as allowed by local law), must understand the nature of the study and must agree to study enrollment.

You may not qualify if:

• Patients who have delirium or dementia
• Prisoners
• Pediatric patients
• Elderly patients
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Aarogyam UK: lead
• NMP Medical Research Institute: collaborator
• Croydon Ayurveda Centre: collaborator
• Active Naturals Limited: collaborator
• AVP Research Foundation: collaborator

Study Sites (2)

Gyansanjeevani

Jaipur, Rajasthan, India

Location

NMP Medical Research Institite

Jaipur, Rajasthan, India

Location

MeSH Terms

Conditions

Mental Disorders; Psychological Well-Being; Emergencies

Interventions

Medicine, Ayurvedic

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medicine, Traditional; Complementary Therapies; Therapeutics

Study Officials

• Neha Sharma

  Aarogyam (UK) CIC

  STUDY DIRECTOR

• Venkata N Joshi

  Croydon Ayurveda Centre

  STUDY CHAIR

• Maël Voegeli

  AVP Research Foundation

  PRINCIPAL INVESTIGATOR

• Skanthesh Lakshmanan

  NMP Medical Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 2, 2022
• Study Start: November 21, 2021
• Primary Completion: December 30, 2021
• Study Completion: January 30, 2022
• Last Updated: February 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)